OCT in Borderline Coronary Artery Lesions

Percutaneous Coronary Intervention (PCI) Clinical Trial

Official title:

The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229993
• Other study ID #: OCT-20170723
• Status: Completed
• Phase: N/A
• Start date: December 31, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.

It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 31, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.

Exclusion Criteria:

• Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.

Related Conditions & MeSH terms

• Borderline Coronary Artery Lesions
• Coronary Angiography (CAG)
• Optical Coherence Tomography (OCT)
• Percutaneous Coronary Intervention (PCI)
• Single-Photon Emission Computed Tomography (SPECT)

Intervention

Diagnostic Test:
• OCT
OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACEs	The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.	12 months
Primary	TLR	The incidence of target lesion revascularization (TLR)	12 months
Secondary	Rehospitalization	The incidence of rehospitalization due to cardiac events	12 months
Secondary	Recurrent angina	The incidence of recurrent angina	12 months